ETS Engineer
Job in
Gaithersburg, Montgomery County, Maryland, 20879, USA
Listed on 2026-06-02
Listing for:
Fladger Associates
Full Time
position Listed on 2026-06-02
Job specializations:
-
Engineering
Validation Engineer, Process Engineer, Pharma Engineer, Manufacturing Engineer -
Manufacturing / Production
Validation Engineer, Manufacturing Engineer
Job Description & How to Apply Below
Gaithersburg, MD
Contract Duration: 6-36 months
Rate:
Negotiable
Salary: NA, $1.00
Responsibilities:
- Excellent employment opportunity for an ETS Engineer I in the Gaithersburg,
MD area. - Responsible for maintaining reliable process equipment performance in one or more manufacturing areas at company's Gaithersburg Clinical Manufacturing facilities including cell culture, purification, and support systems.
- Subject Matter Expert (SME) for biopharmaceutical manufacturing equipment in assigned area(s)
- Resolve daily operational issues in assigned area(s)
- Manage projects and coordinates shutdowns.
- Support new engineering projects. Creates project scopes, URS, and timelines
- Perform troubleshooting, corrections, and process performance optimization
- Monitors bioprocess equipment performance. Identifies equipment issues and helps develop technical solutions
- Determine process requirements. Helps design, install, and commission new processes and equipment
- Write cGMP documentation (SOPs, change controls, validation protocols, etc.)
- Perform quality/safety investigations, and risk evaluations. Owns and executes Quality and Safety CAPAs.
- Perform GMP change control activities.
- Write, track, and execute SAP work orders, and creates and revises Preventative Maintenance plans
- Review specifications, work instructions, protocols, drawings, and reports for technical accuracy
- Provide on-call support and works overtime as needed.
- Schedule --- First Shift: 7:30 am to 4:30 pm, but the exact hours are negotiable
- Candidates without a BS in engineering require a minimum of 2-years of experience in GMP biotech manufacturing
- We are looking for someone with a BS in Engineering. (Chemical Engineering is preferred, Mechanical would be the 2nd choice, and computer science might be an acceptable 3rd choice)
- Prior GMP experience in a biotech or sterile pharmaceutical manufacturing environment a plus. Prior experience with production scale biotech process equipment a plus.
- Prior experience with Trackwise a plus.
- Prior experience with biotech manufacturing would be a plus.
- Good at trouble shooting and problem solving.
- Good oral and written communication skill, and good administrative skills
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×